Lisaftoclax

2024 highlights include UChicago Medicine's research milestones, Ascentage Pharma's presentations on cancer therapies, breakthroughs in cancer detection and treatment, and advancements in plant proteins for cardiovascular health. Innovations in AI and healthcare analytics also mark significant progress in oncology and patient care.

Ascentage Pharma, a Chinese biotech, filed for a $100M IPO. It develops therapies for cancer, hepatitis B, and age-related diseases, with olverembatinib approved in China and lisaftoclax under NDA review. Plans to list on Nasdaq as AAPG.

Ascentage Pharma presented olverembatinib's clinical data at ASH 2024, showing efficacy and safety as a second-line therapy for CP-CML patients, especially those failing first-line TKIs. The drug demonstrated promising response rates and safety, with no new safety signals observed.

China's NMPA's Center for Drug Evaluation accepted lisaftoclax (APG-2575) NDA for priority review in relapsed or refractory CLL/SLL, supported by a phase 2 trial. Ascentage Pharma aims for lisaftoclax to be the first China-developed Bcl-2 inhibitor, following FDA clearance for a phase 3 study in 2023. Early-phase trials showed high ORR with lisaftoclax paired with BTK inhibitors.

Ascentage Pharma's lisaftoclax, a Bcl-2 inhibitor for chronic lymphocytic leukemia, accepted for priority review by China's NMPA, positioning it to be the first approved in China and second globally.

Ascentage Pharma's NDA for lisaftoclax, a Bcl-2 inhibitor for r/r CLL/SLL, was accepted by China's NMPA with Priority Review, potentially making it the first domestically developed Bcl-2 inhibitor in China and the second globally. This follows a Phase II study showing efficacy and safety in Chinese patients with r/r CLL/SLL, addressing a significant unmet need in China where CLL/SLL incidence is rising.

Acelyrin's izokibep phase III trial for HS met its primary endpoint; refocused pipeline strategy prioritizes lonigutamab for TED. Verrica's phase II study for basal cell carcinoma showed promising results, yet stock plunged. US Fed Circuit reinstated Viberzi patents. Ascentage advances lisaftoclax into fourth phase III for MDS treatment.